Abstract
Purpose
Patient-reported outcome measures (PROMs) capture health information from the patient’s perspective that can be used when weighing up benefits, risks and costs of treatment. This is important for elective procedures such as those for coronary revascularisation. Patients should be involved in the development of PROMs to accurately capture outcomes that are important for the patient. The aims of this review are to identify if patients were involved in the development of cardiovascular-specific PROMs used for assessing outcomes from elective coronary revascularisation, and to explore what methods were used to capture patient perspectives.
Methods
PROMs for evaluating outcomes from elective coronary revascularisation were identified from a previous review and an updated systematic search. The studies describing the development of the PROMs were reviewed for information on patient input in their conceptual and/or item development.
Results
24 PROMs were identified from a previous review and three additional PROMs were identified from the updated search. Full texts were obtained for 26 of the 27 PROMs. The 26 studies (11 multidimensional, 15 unidimensional) were reviewed. Only nine studies reported developing PROMs using patient input. For eight PROMs, the inclusion of patient input could not be judged due to insufficient information in the full text.
Conclusions
Only nine of the 26 reviewed PROMs used in elective coronary revascularisation reported involving patients in their conceptual and/or item development, while patient input was unclear for eight PROMs. These findings suggest that the patient’s perspective is often overlooked or poorly described in the development of PROMs.
Similar content being viewed by others
References
U.S. Department of Health and Human Services Food and Drug Administration. (2009). Guidance for industry patient-reported outcomes measures: Use in medical product development to support labeling claims.
McKenna S. P. (2011). Measuring patient-reported outcomes: Moving beyond misplaced common sense to hard science. BMC Medicine, 9(1), 1–12.
Brod, M., Tesler, L. E., & Christensen, T. L. (2009). Qualitative research and content validity: Developing best practices based on science and experience. Quality of Life Research, 18(9), 1263–1278.
Patrick, D. L., Burke, L. B., Gwaltney, C. J., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—eliciting concepts for a new PRO instrument. Value in Health, 14(8), 967–977.
Woodend, A. K., Nair, R. C., & Tang, A. S. (1997). Definition of life quality from a patient versus health care professional perspective. International Journal of Rehabilitation Research, 20(1), 71–80.
Morris, D. B., Wilson, K. G., Clinch, J. J., et al. (2006). Identification of domains relevant to health-related quality of life in patients undergoing major surgery. Quality of Life Research, 15(5), 841–854.
Staniszewska, S., Haywood, K. L., Brett, J., & Tutton, L. (2012). Patient and public involvement in patient-reported outcome measures: Evolution not revolution. Patient, 5(2), 79–87.
Rumsfeld, J. S., Alexander, K. P., Goff, D. C. Jr., et al. (2013). Cardiovascular health: The importance of measuring patient-reported health status: A scientific statement from the American Heart Association. Circulation, 127(22), 2233–2249.
Anker, S. D., Agewall, S., Borggrefe, M., et al. (2014). The importance of patient-reported outcomes: A call for their comprehensive integration in cardiovascular clinical trials. European Heart Journal, 35(30), 2001–2009.
Wijeysundera, H. C., Nallamothu, B. K., Krumholz, H. M., Tu, J. V., & Ko, D. T. (2010). Meta-analysis: Effects of percutaneous coronary intervention versus medical therapy on angina relief. Annals of Internal Medicine, 152(6), 370–379.
Trikalinos, T. A., Alsheikh-Ali, A. A., Tatsioni, A., Nallamothu, B. K., & Kent, D. M. (2009). Percutaneous coronary interventions for non-acute coronary artery disease: A quantitative 20-year synopsis and a network meta-analysis. Lancet, 373(9667), 911–918.
Stergiopoulos, K., & Brown, D. L. (2012). Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: Meta-analysis of randomized controlled trials. Annals of Internal Medicine, 172(4), 312–319.
Thomas, S., Gokhale, R., Boden, W. E., & Devereaux, P. J. (2013). A meta-analysis of randomized controlled trials comparing percutaneous coronary intervention with medical therapy in stable angina pectoris. Canadian Journal of Cardiology, 29(4), 472–482.
Pursnani, S., Korley, F., Gopaul, R., et al. (2012). Percutaneous coronary intervention versus optimal medical therapy in stable coronary artery disease: A systematic review and meta-analysis of randomized clinical trials. Circulation, 5(4), 476–490.
Mackintosh, A., Gibbons, E., Casanas i Comabella, C., & Fitzpatrick, R. (2010). A structured review of patient-reported outcome measures used in elective procedures for coronary revascularisation. Oxford: University of Oxford, Department of Public Health.
Baumeister, H., Abberger, B., Haschke, A., Boecker, M., Bengel, J., & Wirtz, M. (2013). Development and calibration of an item bank for the assessment of activities of daily living in cardiovascular patients using Rasch analysis. Health and Quality of Life Outcomes, 11, 133.
Oldridge, N., Hofer, S., McGee, H., Conroy, R., Doyle, F., & Saner, H. (2014). The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. European journal of preventive cardiology, 21(1), 90–97.
Wan, C., Li, H., Fan, X., et al. (2014). Development and validation of the coronary heart disease scale under the system of quality of life instruments for chronic diseases QLICD-CHD: Combinations of classical test theory and Generalizability Theory. Health and Quality of Life Outcomes, 12, 82.
Nieveen, J. L., Zimmerman, L. M., Barnason, S. A., & Yates, B. C. (2008). Development and content validity testing of the Cardiac Symptom Survey in patients after coronary artery bypass grafting. Heart and Lung, 37(1), 17–27.
Green, C. P., Porter, C. B., Bresnahan, D. R., & Spertus, J. A. (2000). Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: A new health status measure for heart failure. Journal of the American College of Cardiology, 35(5), 1245–1255.
Hillers, T. K., Guyatt, G. H., Oldridge, N., et al. (1994). Quality of life after myocardial infarction. Journal of Clinical Epidemiology, 47(11), 1287–1296.
Hlatky, M. A., Boineau, R. E., Higginbotham, M. B., et al. (1989). A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). American Journal of Cardiology, 64(10), 651–654.
Schroter, S., & Lamping, D. L. (2004). Coronary revascularisation outcome questionnaire (CROQ): Development and validation of a new, patient based measure of outcome in coronary bypass surgery and angioplasty. Heart, 90(12), 1460–1466.
Jenkins, C. D., Stanton, B. A., Savageau, J. A., Denlinger, P., & Klein, M. D. (1983). Coronary artery bypass surgery. Physical, psychological, social, and economic outcomes six months later. JAMA, 250(6), 782–788.
Ferrans, C. E. (1992). Conceptualizations of quality of life in cardiovascular research. Progress in Cardiovascular Nursing, 7(1), 2–6.
Ferrans, C. E., & Powers, M. J. (1985). Quality of life index: Development and psychometric properties. ANS, 8(1), 15–24.
Spertus, J. A., Winder, J. A., Dewhurst, T. A., et al. (1995). Development and evaluation of the Seattle Angina Questionnaire: A new functional status measure for coronary artery disease. Journal of the American College of Cardiology, 25(2), 333–341.
Wan, C., Tu, X., Messing, S., et al. (2011). Development and validation of the general module of the system of quality of life instruments for chronic diseases and its comparison with SF-36. Journal of Pain and Symptom Management, 42(1), 93–104.
Bennett, S. J. (1992). Perceived threats of individuals recovering from myocardial infarction. Heart and Lung, 21(4), 322–326.
Bennett, S. J., Puntenney, P. J., Walker, N. L., & Ashley, N. D. (1996). Development of an instrument to measure threat related to cardiac events. Nursing Research, 45(5), 266–270.
Goldman, L., Hashimoto, B., Cook, E. F., & Loscalzo, A. (1981). Comparative reproducibility and validity of systems for assessing cardiovascular functional class: Advantages of a new specific activity scale. Circulation, 64(6), 1227–1234.
Rose, G. A. (1962). The diagnosis of ischaemic heart pain and intermittent claudication in field surveys. Bull World Health Organ, 27, 645–658.
Rumbaugh, D. M., & Knapp, R. R. (1965). Prediction of work potential in heart patients through use of the cardiac adjustment scale. Journal of Consulting Psychology, 29(6), 597.
Barnason, S., Zimmerman, L., Atwood, J., Nieveen, J., & Schmaderer, M. (2002). Development of a self-efficacy instrument for coronary artery bypass graft patients. The Journal of Nursing Measurement, 10(2), 123–133.
Miller, K. H., & Grindel, C. G. (2004). Comparison of symptoms of younger and older patients undergoing coronary artery bypass surgery. Clinical Nursing Research, 13(3), 179–193.(discussion 194–178).
Plach, S. K., & Heidrich, S. M. (2001). Women’s perceptions of their social roles after heart surgery and coronary angioplasty. Heart and Lung, 30(2), 117–127.
The ENRICHD Investigators. (2000). Enhancing recovery in coronary heart disease patients (ENRICHD): Study design and methods. American Heart Journal, 139(1 Pt 1), 1–9.
Hare, D. L., & Davis, C. R. (1996). Cardiac depression scale: Validation of a new depression scale for cardiac patients. Journal of Psychosomatic Research, 40(4), 379–386.
Peduzzi, P., & Hultgren, H. N. (1979). Effect of medical vs surgical treatment on symptoms in stable angina pectoris. The Veterans Administration Cooperative Study of surgery for coronary arterial occlusive disease. Circulation, 60(4), 888–900.
Sullivan, M. D., LaCroix, A. Z., Russo, J., & Katon, W. J. (1998). Self-efficacy and self-reported functional status in coronary heart disease: A six-month prospective study. Psychosomatic Medicine, 60(4), 473–478.
Moser, D. K., & Dracup, K. (1995). Psychosocial recovery from a cardiac event: The influence of perceived control. Heart and Lung, 24(4), 273–280.
Artinian, N. T., Duggan, C., & Miller, P. (1993). Age differences in patient recovery patterns following coronary artery bypass surgery. American Journal of Respiratory and Critical Care Medicine, 2(6), 453–461.
Keresztes, P., Holm, K., Penckofer, S., & Merritt, S. (1993). Measurement of functional ability in patients with coronary artery disease. Journal of Nursing Measurement, 1(1), 19–28.
Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19(6), 349–357.
Moser, D. K., Riegel, B., McKinley, S., et al. (2009). The Control attitudes scale-revised: Psychometric evaluation in three groups of patients with cardiac illness. Nursing Research, 58(1), 42–51.
LaPier, T. K., & Chunkwon, J. (2002). Development and content validity of the heart surgery symptom inventory. Acute Care Perspectives, 11, 5–12.
Wiering, B., de Boer, D., & Delnoij, D. (2017). Patient involvement in the development of patient-reported outcome measures: A scoping review. Health Expectations, 20(1), 11–23.
Haywood, K. L., Mars, T. S., Potter, R., Patel, S., Matharu, M., & Underwood, M. (2017). Assessing the impact of headaches and the outcomes of treatment: A systematic review of patient-reported outcome measures (PROMs). Cephalalgia. https://doi.org/10.1177/0333102417731348.
Haywood, K. L., Staniszewska, S., & Chapman, S. (2012). Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): A systematic review. Quality of Life Research, 21(1), 35–52.
McLean, S., Holden, M. A., Potia, T., et al. (2017). Quality and acceptability of measures of exercise adherence in musculoskeletal settings: A systematic review. Rheumatology, 56(3), 426–438.
Bredart, A., Marrel, A., Abetz-Webb, L., Lasch, K., & Acquadro, C. (2014). Interviewing to develop patient-reported outcome (PRO) measures for clinical research: Eliciting patients’ experience. Health and Quality of Life Outcomes, 12, 15.
Lasch, K. E., Marquis, P., Vigneux, M., et al. (2010). PRO development: Rigorous qualitative research as the crucial foundation. Quality of Life Research, 19(8), 1087–1096.
Boers, M., Brooks, P., Simon, L. S., Strand, V., & Tugwell, P. (2005). OMERACT: An international initiative to improve outcome measurement in rheumatology. Clinical and Experimental Rheumatology, 23(5 Suppl 39), S10–S13.
Gargon, E., Williamson, P. R., Altman, D. G., Blazeby, J. M., & Clarke, M. (2014). The COMET Initiative database: Progress and activities from 2011 to 2013. Trials, 15, 279.
McNamara, R. L., Spatz, E. S., Kelley, T. A., et al. (2015). Standardized outcome measurement for patients with coronary artery disease: Consensus from the International Consortium for Health Outcomes Measurement (ICHOM). Journal of the American Heart Association, 4(5), e001767
Peduzzi, P., & Hultgren, H. (1985). Angina scoring method in the Veterans Administration randomized study of bypass surgery. American Journal of Epidemiology, 122(3), 477–484.
Patrick, D. L., Burke, L. B., Powers, J. H., et al. (2007). Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value in Health, 10(Suppl 2), S125–S137.
Mokkink, L. B., Terwee, C. B., Knol, D. L., et al. (2010). The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: A clarification of its content. BMC Medical Research Methodology, 10, 22.
Lim, L. L., Valenti, L. A., Knapp, J. C., et al. (1993). A self-administered quality-of-life questionnaire after acute myocardial infarction. Journal of Clinical Epidemiology, 46(11), 1249–1256.
Jenkins, C. D., Jono, R. T., Stanton, B. A., Stroup-Benham, C. A., (1990). The measurement of health-related quality of life: major dimensions identified by factor analysis. Social Science Medicine, 31(8), 925–931.
Rose, G. A., Blackburn, H. (1968). Cardiovascular survey methods. Monograph Series World Health Organization, 56, 1–188.
Funding
The project was supported by a Medibank Health Research Fund (Application Number: 2014-044, Melbourne, Australia). The funding source had no influence on the study design, data collection and analyses, interpretation and decision to publish.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Peeters, G., Barker, A.L., Talevski, J. et al. Do patients have a say? A narrative review of the development of patient-reported outcome measures used in elective procedures for coronary revascularisation. Qual Life Res 27, 1369–1380 (2018). https://doi.org/10.1007/s11136-018-1795-6
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11136-018-1795-6